Mots-clé
(Allemand)
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Impfstoffkontrolle, Qualitätskontrolle, Nukleinsäurevakzinen, Impfstofftechnologie, Sicherheit, Risikoanalyse, tierische Lebensmittel
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Mots-clé
(Anglais)
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vaccine control, quality control, Nucleic acid vaccines, DNA vaccines, new generation vaccines, safety and efficacy, risk assessment, food producing animals
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Description succincte
(Allemand)
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In diesem Projekt sollen die Probleme rund um die Sicherheit von Nukleinsäurevakzinen evaluiert werden. Das Know-How auf dem Gebiet der Nukleinsäurevakzine für die Kontrollstelle soll einerseits mittels Laboruntersuchungen aus Materialien aus bereits durchgeführten Versuchen (Projekt Hundestaupe (Prof. A. Zurbriggen und IVI) stattfinden, andererseits sollen Verfahren evaluiert werden, die zur Abklärung relevanter Probleme (Plasmidresistenz im Zieltier, Integration ins Genom, Promotoraktivitäten im Zieltier, Qualität der Nukleinsäure für die Impfung, Risiken aus tierischen Lebensmittel usw. ...) dienen.
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Description succincte
(Anglais)
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DNA vaccination is a rapidly developing technology that offers new approaches for the prevention of disease. This technology may permit the production of new vaccines against diseases that have no current vaccine, as well as allowing the development of improved vaccines to replace existing products.
Vaccination as a means of disease prevention in livestock production and veterinary field is essential for an economically sound and reliable food-animal industry. Vaccines are routinely used to control a number of economically important pathogens, and as new diseases emerge there is likely to be a need for the develop-ment of new vaccines.
Usefullness of vaccines depend on a favorable balance of efficay, safety and and cost.
The safety aspects of nucleic acid vaccines as well as regulatory viewpoints need to be adressed. This project is intended to asses the requirements for veterinary nucleic acid vaccines which include safety assements for animals, the environment and humans. The risk analysis should also take into account the public concerns that might be an important impact factor.
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Objectifs du projet
(Allemand)
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Erarbeiten der Expertise von neuen zukünftigen Impfstoffen; Erkennen der relevanten Probleme bei Nukleinsäurevakzinen; Erarbeiten und Umsetzung von regulatorischen Anforderungen; Etablieren von Kontakten zu Behörden und Organisationen (national / international) sowie Erfahrungsaustausch mit Impfstoffherstellern.
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Objectifs du projet
(Anglais)
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Development of regulatory strategies.
Use of DNA vaccines in (food producingl) animals will require the development of new regulations for their testing and use. There will be a need for the vaccine control unit to provide the expertise and knowledge in order to assist and advise vaccine manufacturerer since current guidelines have limiteld applicability for plasmid DNA vaccines. New generation of products require new approaches to control DNA vaccines.
Assessment of relevant safety aspects of DNA vaccines.
One of the safety issues surrounding the is the potential for DNA integration into the genome of the host. Specifically, plasmid DNA might integrate into the chromosomal DNA of a somatic cell and this could lead to insertional mutagenesis by activation of a proto-oncogene or by inactivation of a tumor suppressor gene.
Evaluation of potential immunopathological adverse reactions
Another safety concern is the inadvertent stimulation of anti-DNA antibodies which could cause autoimmune disease.
Numerous other questions need to be adressed, such as local reactogenicity and systemic toxicity, reproduc-tive toxicity, tumorigenicity, safety assessments for animals, humans and the environment, as well as food products derived from vaccinated animals. Furthermore care should be taken to genes confering drug resis-tance for selection of the plasmid and the possibility of read-through. In safety studies consideration has to be given to the mode, route and site of inoculation and the dosage.
Participation on establishing (international) guidelines on assuring the quality of DNA vaccines. The impor-tance of both the host strain and the growth conditions on the quality of the final plasmid need to be consid-ered.
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Publications / Résultats
(Anglais)
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Documents annexés
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